FDA.report

INTEGRA LIFESCIENCES CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
11213081121308INTEGRA LIFESCIENCES CORPORATION1N2026-01-01105 and 109 MORGAN LANE PLAINSBORO NJ US 08536
30034183253003418325Integra LifeSciences Corporation1Y2026-01-011100 Campus Road Princeton NJ US 08540
30046088783004608878INTEGRA LIFESCIENCES CORPORATION1N2026-01-014900 CHARLEMAR DR., BUILDING A CINCINNATI OH US 45227

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
129781003374937P900033INTEGRA DERMAL REGENERATION TEMPLATEMGR1996-03-01
129781003374937P900033INTEGRA DERMAL REGENERATION TEMPLATEMGR1996-03-01
129671003374937P900033INTEGRA DERMAL REGENERATION TEMPLATEMGR1996-03-01
129671773461133P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGELMF1985-11-08
129781773461133P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGELMF1985-11-08
129781773461133P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGELMF1985-11-08
129671815776200P840062COLLACOTE(TM)LPG1985-11-08
129781815776200P840062COLLACOTE(TM)LPG1985-11-08
129781815776200P840062COLLACOTE(TM)LPG1985-11-08
129671115660182P810006COLLASTATLMF1981-12-10
129781115660182P810006COLLASTATLMF1981-12-10
129781115660182P810006COLLASTATLMF1981-12-10
129781989060182P080013DURASEAL EXACT SPINE SEALANT SYSTEMNQR2009-09-04
129781438477060P040034DURASEAL DURAL SEALANT SYSTEMNQR2005-04-07
129781965663980P000057ASCENSION MCPNEG2001-11-19
129781518611594K993762I.CO.S SCREWHWC2000-02-04
129781276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
129801276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
129782044560934K993653MICRO-FRANCE TROCARS AND ACCESSORIESHET2000-06-09
129802044560934K993653MICRO-FRANCE TROCARS AND ACCESSORIESHET2000-06-09
129781311601127K993594CONFORMAX MMLC VR1IYE1999-12-15
129781188657007K992732STERILE WATER & STERILE 0.9% SODIUM CHLORIDEFOZ2000-04-20
129781776172260K992591CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITSGWM1999-10-15
129671804661727K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANELYC1999-07-26
129781804661727K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANELYC1999-07-26
129781804661727K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANELYC1999-07-26
129781428097792K992173SIPHONGUARD CSF CONTROL DEVICEJXG2000-04-07
129802065150661K991873KMI WRIST FUSION SYSTEMHRS1999-08-17
129782065150661K991873KMI WRIST FUSION SYSTEMHRS1999-08-17
129782047955677K991566SOLUSTAPLEJDR1999-08-03
129781733607005K991523TLC PEDIATRIC FRAME, MODEL TLC-SYSIYE1999-07-30
129781805210830K991482UNI-CLIP STAPLEJDR1999-06-03
129781202346969K991477SPIN SNAP-OFF SCREWHWC1999-07-14
129781088532226K991413CODMAN ETHISORB DURA PATCHGXQ2000-03-13
129781093635698K991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITGWM1999-07-09
129781584601322K990622BOLD SCREWHWC1999-04-29
129781421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129801421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129781894017646K982549RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLCIYE1998-12-30
129781783902218K982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERHCI1998-12-18
129782017435437K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
129802017435437K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
129781265329691K982294XOMED SILICONE PRE-FORM BLOCKSKHJ1998-09-18
129671604503948K982180DURAGEN DURAL GRAFT MATRIXGXQ1999-07-06
129781604503948K982180DURAGEN DURAL GRAFT MATRIXGXQ1999-07-06
129781604503948K982180DURAGEN DURAL GRAFT MATRIXGXQ1999-07-06
129801880935097K981919BISSINGER CABLES, CAT. NO. 801000XXGEI1998-08-06
129781880935097K981919BISSINGER CABLES, CAT. NO. 801000XXGEI1998-08-06
129781284442575K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
129801145214770K981597RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITYIYE1998-10-09
129781145214770K981597RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITYIYE1998-10-09
129781408053185K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL1998-07-06
129781403741746K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTKWH1998-06-30
129781076531964K980861DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGELMGQ1998-05-20
129781869570346K980791DUMEX PAK-ITS WOVEN RIBBON PACKINGEFQ1998-04-29
129801642441399K980584ATLASPLANHAW1998-05-18
129781642441399K980584ATLASPLANHAW1998-05-18
129781827908289K980448MODEL PS-1 PENA MUSCLE STIMULATORIPF1998-04-03
129781293444010K974739HAKIM PROGRAMMABLE VALVE SYSTEMJXG1998-07-01
129781578640015K974726SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETERJXG1998-03-18
129781964117342K974708GEMINI STANDARD AND MINI VALVESJXG1998-03-10
129781839003887K974088CODMAN INTRACRANIAL BOLTGWM1998-01-09
129781505347487K973774CODMAN HAKIM MICRO PRECISION VALVEJXG1997-12-29
129781238886251K973525MAURICE WORLDWIDE SHUNT SYSTEMJXG1997-12-16
129781027266655K972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSJXG1997-11-03
129781608911441K971617ENDOSCOPIC VENTRICULAR CATHETERJXG1997-07-31
129781894235753K970983PERITONEAL/CARDIAC CATHETERJXG1997-06-13
129781085205304K970910XOMED SILICONE BLOCK/STRIPKHJ1997-05-02
129781297804740K970658LUMBAR DRAINAGE ACCESSORY KITJXG1997-05-19
129781389925282K964371SHUNT TAP WITH ICP MONITORING ACCESS PORTJXG1997-01-31
129781964666166K963802SHUNT TAPJXG1996-12-12
129781343517402K963499MIRROR FINISH BIPOLAR FORCEPSGEI1996-10-08
129781214703546K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)GWM1996-12-20
129781815261204K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
129781874914182K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
129801292517985K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYIYE1996-08-22
129781292517985K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYIYE1996-08-22
129781745465512K961859NOVUS STANDARD AND PEDIATRIC VALVESJXG1996-12-16
129781856315332K961858COSGROVE DEPTH ELECTRODE KIT(CDEK)HAW1996-08-07
129801856315332K961858COSGROVE DEPTH ELECTRODE KIT(CDEK)HAW1996-08-07
129781254607734K961113CNS INTERCHANGEABLE BIT CRANIAL DRILLHBG1996-06-05
129781650302083K960815DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLLNAD1996-04-29
129781014476569K960807TEW CRANIAL/SPINAL RETRACTOR MODEL A1090GZT1996-05-17
129801014476569K960807TEW CRANIAL/SPINAL RETRACTOR MODEL A1090GZT1996-05-17
129802028583999K960692SUBTALAR MBA SYSTEMHWC1996-07-23
129782028583999K960692SUBTALAR MBA SYSTEMHWC1996-07-23
129782043936071K960248GENERAL PROCEDURE KITFMF1996-04-12
129781641649783K960159CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)JXG1996-10-25
129781201408899K960100SPINAL SPECIALTIES NERVE BLOCK TRAYCAZ1996-04-24
129781136422705K960082DISCOGRAPHY KITIZG1996-03-21
129781909342503K955832CORDIS VENTRICULAR ANTECHAMBER (VA)JXG1996-03-25
129782056522732K955265CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETERJXG1996-12-20
129782021815686K954743DERMAGRAN WOUND DRESSING CLEANER W/ZINCFRO1995-11-02
129781859661247K954739DERMAGRAN HYDROPHILIC OINTMENTFRO1995-11-02
129781059353929K954738DERMAGRAN HYDROPHILIC WOUND DRESSINGMGP1995-11-02
129781681748476K953124MAYFIELD RADIOLUCENT 2000 SKULL CLAMPHBL1996-02-09
129801681748476K953124MAYFIELD RADIOLUCENT 2000 SKULL CLAMPHBL1996-02-09
129781758140045K950820SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLEBSP1995-06-30
129781977942307K950646INTEGRATORLXM1996-04-30
129781655835660K950315CORDIS CSF RESERVOIRLKG1995-05-09
129781752908724K950132DUMEX WET DRESSINGSFRO1995-03-01
129781435460671K946326DUTEX GAUZE BANDAGEEFQ1995-01-24
129781481333891K945830DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)EFQ1995-01-11
129781202396442K945802DERMAGRAN WOUND CLEANSER WITH ZINCKMF1995-02-27
129781347427456K945585COMAN(R) CU-11 MODEL NUMBER 82-6634GWM1995-10-26
129781916327773K945541SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALEHKY1995-05-08
129781936646819K945484PIDURAL STEROID SYSTEMCAZ1995-06-02
129782034426250K945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPESGCJ1995-02-23
129802034426250K945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPESGCJ1995-02-23
129781630812658K944870JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680GCJ1994-11-02
129801630812658K944870JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680GCJ1994-11-02
129781301240529K944670JARIT RECOMMENDED SINUS INSTRUMENTSEOB1995-02-02
129781591075748K944656OPTUS SINUSCOPES AND ACCESSORIESEOB1995-01-26
129781018648418K944595CORDIS HORIZONTAL-VERICAL VALVE SYSTEMJXG1995-10-19
129801103965614K944463CRW-1 SYSTEMHAW1995-10-26
129781103965614K944463CRW-1 SYSTEMHAW1995-10-26
129781185205031K944222CODMAN-MEDOS VALVE SHUNT SYSTEMJXG1995-07-28
129781033582252K942863EPIDURAL NEEDLEBSP1995-08-11
129781670417272K941565JARIT RECOMMENDED SINUS INSTRUMENTSEOB1994-05-16
129801583206643K941558MAYFIELD CHILD DISPOSABLE SKULL PINHBL1995-12-06

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JXG852024-01-17
HRS342013-08-07
HBL302014-11-24
GEI292021-12-02
HWC262015-10-29
GWM242024-02-04
KGN232024-07-11
LFL232023-07-11
GXQ222016-11-02
GCJ182012-09-11
HAW162016-12-06
FRO152015-11-19
KCT142024-03-22
IYE142010-04-22
MQV122014-08-01
PGW102023-07-21
LRC102020-08-27
FTM92019-02-07
HSN82018-12-18
JXI82017-01-06
DXC82013-05-14
JDR82013-05-03
GWG72025-04-09
JOJ62016-06-28
JWJ62014-03-24
KWD62010-01-14
LYC61999-07-26
LMF61985-11-08
KWS52015-12-23
EOB52011-05-27
HBG51996-06-05
GYK51993-08-23
DWP42019-09-03
HBF42019-01-20
HSB42018-11-02
HTY42012-03-20
MUJ42010-04-08
FMF42009-06-05
KWH42003-01-17
GZT41996-05-17

PMA

Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

2022-12-19

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS104 Date Received11/21/2022 Decision Date12/19/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

DuraSeal Dural Sealant System

2022-10-07

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP040034 Supplement NumberS035 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proc...

DuraSeal Exact Spine Sealant System

2022-10-07

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP080013 Supplement NumberS024 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proc...

Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

2022-07-06

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS103 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

2022-05-20

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS102 Date Received04/20/2022 Decision Date05/20/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

Helistat and Helitene Absoibable Collagen Hemostatic Agents

2022-04-20

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS100 Date Received03/21/2022 Decision Date04/20/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

PMN

Applications

GUDID

Durepair®

2026-03-11

Integra Lifesciences Corporation

Durepair®

2026-03-11

Integra Lifesciences Corporation

Durepair®

2026-03-11

Integra Lifesciences Corporation

Durepair®

2026-03-11

Integra Lifesciences Corporation

MAYFIELD®

2026-02-05

INTEGRA LIFESCIENCES CORPORATION

MAYFIELD®

2026-02-05

INTEGRA LIFESCIENCES CORPORATION

MAYFIELD®

2025-08-25

INTEGRA LIFESCIENCES CORPORATION

DuraSeal®

2025-02-17

Integra Lifesciences Corporation

DuraSeal®

2025-02-17

Integra Lifesciences Corporation